BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEVO-S

    MDR report key: 3234014 · Received July 11, 2013

    Report

    Report Number
    8010042-2013-00106
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K041223
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    MORE INFO SURROUNDING THE EVENT HAS BEEN SOUGHT. A SUPPLEMENTAL MEDWATCH WILL BE PROVIDED WHEN THE INVESTIGATION IS FINISHED. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319657 SEVO-S CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1